WO2014179022A1 - Stent delivery and deployment methods and apparatus - Google Patents

Stent delivery and deployment methods and apparatus Download PDF

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Publication number
WO2014179022A1
WO2014179022A1 PCT/US2014/034038 US2014034038W WO2014179022A1 WO 2014179022 A1 WO2014179022 A1 WO 2014179022A1 US 2014034038 W US2014034038 W US 2014034038W WO 2014179022 A1 WO2014179022 A1 WO 2014179022A1
Authority
WO
WIPO (PCT)
Prior art keywords
scaffold
distal
inflatable balloon
tapered
defines
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2014/034038
Other languages
English (en)
French (fr)
Inventor
Kamal Ramzipoor
Chang Y. Lee
Edward A. Estrada
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amaranth Medical Pte
Original Assignee
Amaranth Medical Pte
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amaranth Medical Pte filed Critical Amaranth Medical Pte
Priority to JP2016511751A priority Critical patent/JP2016518931A/ja
Priority to HK16106767.0A priority patent/HK1218707B/en
Priority to CN201480024968.6A priority patent/CN105188603A/zh
Priority to AU2014260410A priority patent/AU2014260410A1/en
Priority to CA2911196A priority patent/CA2911196A1/en
Priority to EP14791418.8A priority patent/EP2991581B1/en
Priority to SG11201508852SA priority patent/SG11201508852SA/en
Publication of WO2014179022A1 publication Critical patent/WO2014179022A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • A61F2002/9586—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve the means being inside the balloon

Definitions

  • the present invention relates generally to stent or scaffold delivery and deployment methods and apparatus. More particularly, the present invention relates to methods and apparatus for providing a smooth transition between a crimped stent and inflation balloon for facilitating intravascular deliveiy and deployment of the stent or scaffold.
  • the edges 16 of the scaffold 12 may protrude radially at the balloon-scaffold transition, as shown in the side view of Fig. 1 A, and prevent smooth intravascular navigation to the target site.
  • a scaffold delivery apparatus may generally comprise a catheter having an inflatable balloon thereupon, an expandable scaffold secured upon the inflatable balloon, and a distal spacer positioned beneath or within the inflatable balloon at a location distal to the scaffold, wherein the distal spacer is tapered to widen from a distal end to a proximal end adjacent to the scaffold.
  • the scaffold delivery apparatus may generally comprise an inflatable balloon positioned upon a catheter, and an expandable scaffold secured upon the inflatable balloon, wherein a distal portion of the inflatable balloon defines a tapered transition adjacent to a distal end of the scaffold and a proximal portion of the inflatable balloon defines a tapered transition adjacent to the proximal end of the scaffold.
  • the scaffold delivery apparatus may generally comprise an inflatable balloon positioned upon a catheter, and an expandable scaffold secured upon the inflatable balloon, wherein the scaffold defines at least a distal tapered edge.
  • the scaffold delivery apparatus may generally comprise a catheter having an inflatable balloon thereupon, an expandable scaffold secured upon the inflatable balloon, a distal spacer positioned beneath or within the inflatable balloon at a location distal to the scaffold, wherein the distal spacer is tapered to widen from a distal end to a proximal end adjacent to the scaffold, and wherein a distal portion of the inflatable balloon defines a tapered transition adjacent to a distal end of the scaffold and a proximal portion of the inflatable balloon defines a tapered transition adjacent to the proximal end of the scaffold.
  • the scaffold delivery apparatus may generally comprise a catheter having an inflatable balloon thereupon, an expandable scaffold secured upon the inflatable balloon, a distal spacer positioned beneath or within the inflatable balloon at a location distal to the scaffold, wherein the distal spacer is tapered to widen from a distal end to a proximal end adjacent to the scaffold, and wherein the scaffold defines at least a distal tapered edge.
  • the scaffold delivery apparatus may generally comprise a catheter having an inflatable balloon thereupon, an expandable scaffold secured upon the inflatable balloon, wiierein a distal portion of the inflatable balloon defines a tapered transition adjacent to a distal end of the scaffold and a proximal portion of the inflatable balloon defines a tapered transition adjacent to the proximal end of the scaffold, and wherein the scaffold defines at least a distal tapered edge.
  • the scaffold delivery apparatus may generally comprise a catheter having an inflatable balloon thereupon, an expandable scaffold secured upon the inflatable balloon, a distal spacer positioned beneath or within the inflatable balloon at a location distal to the scaffold, wiierein the distal spacer is tapered to widen from a distal end to a proximal end adjacent to the scaffold, wherein a distal portion of the inflatable balloon defines a tapered transition adjacent to a distal end of the scaffold and a proximal portion of the inflatable balloon defines a tapered transition adjacent to the proximal end of the scaffold, and wherein the scaffold defines at least a distal tapered edge.
  • the scaffold delivery method may generally comprise providing a catheter having an inflatable balloon thereupon, an expandable scaffold secured upon the inflatable balloon, and a distal spacer positioned beneath or within the inflatable balloon at a location distal to the scaffold, wherein the distal spacer is tapered to widen from a distal end to a proximal end adjacent to the scaffold, and inflating the balloon such that the scaffold is expanded radially beyond the distal spacer.
  • Fig. 1 A shows a side view of a scaffold crimped upon a balloon illustrating the exposed scaffold edges which may hinder navigation of the assembly through the vasculature.
  • Figs. IB and IC show side views of one variation of an assembly having tapered spacers underneath or within the distal and proximal portions of the inflation balloon which prevent radial exposure of the scaffold edges.
  • Figs. 2A and 2B show side views of another variation of an assembly where the distal and proximal portions of the inflation balloon abutting the scaffold may be specially shaped in a tapered manner to prevent radial exposure of the scaffold edges.
  • Figs. 3A and 3B show side views of yet another variation of an assembly where the distal and proximal portions of the scaffold may be shaped or tapered to present a smooth transition between the catheter, inflation balloon, and scaffold.
  • scaffolds 12 with wall thicknesses greater than 50 ⁇ it is possible to improve intravascular navigation by creating a smoother transition from balloon-to-scaffold.
  • One method of creating this smooth transition is to place spacers underneath or within the balloon 14 that will increase the diameter of balloon 14 just prior and/or just after the scaffold, as shown in the side view of Fig. IB.
  • a distal spacer 18 which is tapered to widen radially from its distal end to its proximal end may be positioned distal to the scaffold 12.
  • a similar proximal spacer 20 which is tapered to narrow radially from its distal end to its proximal end may be positioned proximal to the scaffold 12 as well.
  • the widened ends of the spacers 18, 20 may have a diameter which is similar or the same as the diameter of the crimped scaffold 12 secured upon the balloon 14 to prevent the scaffold edges 16 from protruding beyond the spacers 18, 20 during intravascular delivery.
  • the diameter of the crimped balloon 14 at the spacer regions can range from one wall thickness less than the crimped diameter of the scaffold 12 to two wall thickness greater than crimped diameter of the scaffold 12.
  • the inflation balloon 14 may be simply expanded as normally done to expand the scaffold 12 beyond the diameter of the spacers 18, 20, as shown in the side view of Fig. 1C.
  • FIG. 2 A and 2B show r an inflation balloon 14 which is specially configured to define a step 30, 32 in the balloon 14 to accommodate the diameter change due to scaffold wall thickness.
  • the distal step 30 may be defined by the balloonl4 distal to the scaffold 12 and the proximal step 32 may be defined by the balloon 14 proximal to the scaffold 12 such that the steps 30, 32 abut the scaffold 12 in a tapered manner to present a smooth balloon-scaffold transition.
  • the balloon 14 may be inflated normally for deployment into the body lumen.
  • Figs. 3 A and 3B show side views of yet another variation where the distal 40 and proximal edges 42 of the scaffold 12 may be tapered.
  • the uansitioning scaffold edges 40, 42 can be created using methods including, e.g., angled laser beam, profile machining, control depth profile machining, using laser beam or other mechanisms, injection molding process, abrasive or material removal process, as well as other material removal/deposit processes.
  • the balloon 14 may be simply inflated as normal for stent deployment, as shown in Fig. 3B.
  • the stent 14 can also be made thinner to smooth the balloon-scaffold transition.
  • the thinned stent 14 as well as each of the transition features described herein may be used in any number of combinations.
  • the spacers 18, 20 may be used in combination with the tapered balloon edges 30, 32 in a single assembly.
  • these features may also be used in combination with the tapered scaffold edges 40, 42 in any variation.
  • the transition features described herein may be used with any number of scaffolds or stent structures and particularly with polymeric substrate and stent assemblies as described in U.S. Pat. Apps. 10/867,617 filed June 15, 2004 (U.S. Pub.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
PCT/US2014/034038 2013-05-03 2014-04-14 Stent delivery and deployment methods and apparatus Ceased WO2014179022A1 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
JP2016511751A JP2016518931A (ja) 2013-05-03 2014-04-14 ステント供給及び展開の方法及び装置
HK16106767.0A HK1218707B (en) 2013-05-03 2014-04-14 Stent delivery apparatus
CN201480024968.6A CN105188603A (zh) 2013-05-03 2014-04-14 支架输送和铺展方法及其装置
AU2014260410A AU2014260410A1 (en) 2013-05-03 2014-04-14 Stent delivery and deployment methods and apparatus
CA2911196A CA2911196A1 (en) 2013-05-03 2014-04-14 Stent delivery and deployment methods and apparatus
EP14791418.8A EP2991581B1 (en) 2013-05-03 2014-04-14 Stent delivery apparatus
SG11201508852SA SG11201508852SA (en) 2013-05-03 2014-04-14 Stent delivery and deployment methods and apparatus

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361819337P 2013-05-03 2013-05-03
US61/819,337 2013-05-03

Publications (1)

Publication Number Publication Date
WO2014179022A1 true WO2014179022A1 (en) 2014-11-06

Family

ID=51841869

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/034038 Ceased WO2014179022A1 (en) 2013-05-03 2014-04-14 Stent delivery and deployment methods and apparatus

Country Status (8)

Country Link
US (1) US20140330359A1 (enExample)
EP (1) EP2991581B1 (enExample)
JP (1) JP2016518931A (enExample)
CN (1) CN105188603A (enExample)
AU (1) AU2014260410A1 (enExample)
CA (1) CA2911196A1 (enExample)
SG (2) SG11201508852SA (enExample)
WO (1) WO2014179022A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12076240B2 (en) * 2020-08-24 2024-09-03 Medtronic, Inc. Devices and methods for delivery and deployment of balloon expandable transcatheter valves
CN119896797A (zh) * 2023-12-19 2025-04-29 元心科技(深圳)有限公司 球囊、球囊扩张导管及支架系统

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5639274A (en) * 1995-06-02 1997-06-17 Fischell; Robert E. Integrated catheter system for balloon angioplasty and stent delivery
US6106530A (en) * 1997-01-24 2000-08-22 Terumo Kabushiki Kaisha Stent delivery device
US6585747B1 (en) * 2000-04-14 2003-07-01 Advanced Cardiovascular Systems, Inc. Interdigitating polymeric endcap for enhanced stent retention
US20050021131A1 (en) 2003-06-16 2005-01-27 Subramanian Venkatraman Polymeric stent and method of manufacture
US20100042202A1 (en) 2008-08-13 2010-02-18 Kamal Ramzipoor Composite stent having multi-axial flexibility
US20100274344A1 (en) * 1996-08-23 2010-10-28 Boston Scientific Scimed, Inc. Stent Delivery System Having Stent Securement Apparatus
US20110099785A1 (en) 2003-01-27 2011-05-05 Stephen Dirk Pacetti Drug-eluting stent and delivery system with tapered stent in shoulder region
US8152819B2 (en) * 1996-08-23 2012-04-10 Boston Scientific Scimed, Inc. Catheter support for stent delivery
US8206635B2 (en) 2008-06-20 2012-06-26 Amaranth Medical Pte. Stent fabrication via tubular casting processes
US8206636B2 (en) 2008-06-20 2012-06-26 Amaranth Medical Pte. Stent fabrication via tubular casting processes
US8309023B2 (en) 2009-01-20 2012-11-13 Amaranth Medical Pte. Sterilization methods and apparatus

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6395008B1 (en) * 1996-08-23 2002-05-28 Scimed Life Systems, Inc. Stent delivery device using stent cups and mounting collars
US6007543A (en) * 1996-08-23 1999-12-28 Scimed Life Systems, Inc. Stent delivery system with stent securement means
US6059822A (en) * 1997-08-22 2000-05-09 Uni-Cath Inc. Stent with different mesh patterns
US6626939B1 (en) * 1997-12-18 2003-09-30 Boston Scientific Scimed, Inc. Stent-graft with bioabsorbable structural support
US6200325B1 (en) * 1999-03-31 2001-03-13 Advanced Cardiovascular Systems, Inc. Balloon catheter and stent deploying catheter system
US6544218B1 (en) * 2000-07-26 2003-04-08 Advanced Cardiovascular Systems, Inc. Catheter with biased shaft
US7105014B2 (en) * 2002-11-22 2006-09-12 Medtronic Vascular, Inc. Stent delivery and retention apparatus
US7381048B2 (en) * 2005-04-12 2008-06-03 Advanced Cardiovascular Systems, Inc. Stents with profiles for gripping a balloon catheter and molds for fabricating stents
US8795346B2 (en) * 2006-11-20 2014-08-05 Boston Scientific Scimed, Inc. Semi rigid edge protection design for stent delivery system

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5639274A (en) * 1995-06-02 1997-06-17 Fischell; Robert E. Integrated catheter system for balloon angioplasty and stent delivery
US8152819B2 (en) * 1996-08-23 2012-04-10 Boston Scientific Scimed, Inc. Catheter support for stent delivery
US20100274344A1 (en) * 1996-08-23 2010-10-28 Boston Scientific Scimed, Inc. Stent Delivery System Having Stent Securement Apparatus
US6106530A (en) * 1997-01-24 2000-08-22 Terumo Kabushiki Kaisha Stent delivery device
US6585747B1 (en) * 2000-04-14 2003-07-01 Advanced Cardiovascular Systems, Inc. Interdigitating polymeric endcap for enhanced stent retention
US8057526B2 (en) * 2003-01-27 2011-11-15 Abbott Cardiovascular Systems Inc. Drug-eluting stent and delivery system with tapered stent in shoulder region
US20110099785A1 (en) 2003-01-27 2011-05-05 Stephen Dirk Pacetti Drug-eluting stent and delivery system with tapered stent in shoulder region
US20050021131A1 (en) 2003-06-16 2005-01-27 Subramanian Venkatraman Polymeric stent and method of manufacture
US8206635B2 (en) 2008-06-20 2012-06-26 Amaranth Medical Pte. Stent fabrication via tubular casting processes
US8206636B2 (en) 2008-06-20 2012-06-26 Amaranth Medical Pte. Stent fabrication via tubular casting processes
US20120232643A1 (en) 2008-06-20 2012-09-13 Amaranth Medical Pte. Stent fabrication via tubular casting processes
US20120232644A1 (en) 2008-06-20 2012-09-13 Amaranth Medical Pte. Stent fabrication via tubular casting processes
US20100042202A1 (en) 2008-08-13 2010-02-18 Kamal Ramzipoor Composite stent having multi-axial flexibility
US8309023B2 (en) 2009-01-20 2012-11-13 Amaranth Medical Pte. Sterilization methods and apparatus

Also Published As

Publication number Publication date
EP2991581A4 (en) 2016-11-02
US20140330359A1 (en) 2014-11-06
CN105188603A (zh) 2015-12-23
EP2991581A1 (en) 2016-03-09
SG11201508852SA (en) 2015-11-27
EP2991581B1 (en) 2018-06-06
AU2014260410A1 (en) 2015-11-12
CA2911196A1 (en) 2014-11-06
HK1218707A1 (en) 2017-03-10
JP2016518931A (ja) 2016-06-30
SG10201709037VA (en) 2017-12-28

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